Pralatrexate Combined With Chidamide Bridging Allogeneic HSCT for Refractory/Relapsed Peripheral T-cell Lymphoma

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking University People's Hospital

About this trial

This is a multicenter, prospective study of Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory/Relapsed Peripheral T-cell Lymphoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients fully understand the study, voluntarily participate in and sign on the informed consent;

Diagnosed by histopathology Peripheral T-cell lymphoma;

ECOG PS score 0 or 1;

Relapsed or Refractory Peripheral T Cell Lymphoma;

Disqualifiers

NK/T-cell lymphoma;

Achieving CR or PR after induction chemotherapies without relapse;

Dysfunction of vital organs;

Serious history of autoimmune diseases and immunodeficiency, including: positive for human immunodeficiency virus (HIV) antibodies; Or other acquired or congenital immunodeficiency diseases; Or have a history of organ transplantation;

Trial design

Design model

Single group

Treatments tested in this trial

  • Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation

    Other intervention

    Drug: Pralatrexate, Chidamide 1. Pralatrexate: 30 mg/m2 intravenously (IV) administered weekly in 6-week cycles. Chidamide: 20mg, twice a week in 3-week cycles (2 weeks on treatment, 1 week off treatment) 2. After the 6-week therapy, the patients should receive PET/CT evaluation. 3. Patients would receive allo-HSCT if they could achieve at least PR after the first cycle of therapy. For the patients could not achieve a least PR after the first cycle of therapy, they should receive a second cycle of pralatrexate combined with chidamide. The interval between two cycles of pralatrexate combined with chidamide should be at least 1 week. 4. After the second cycle of 6-week therapy, the patients should receive PET/CT evaluation. Patients would receive allo-HSCT if they could achieve at least SD after the second cycle of therapy. For the patients could not achieve a least SD after the second cycle of therapy, they should receive other salvage therapies.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Pralatrexate combined with Chidamide bridging allo-HSCT for Relapse/Refractory PTCL patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS) at 1 year after transplantation

The time from the end of transplantation to progression of disease or death at 1year

Time frame
Participants will be followed for an expected average of 1 years after transplantation

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University People's Hospital

Lead sponsor

Ruijin Hospital

Collaborator

Wuhan TongJi Hospital

Collaborator

West China Hospital

Collaborator

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